ACTRN12624000953538尚未招募未知
Whole body 360 Degree, 3-Dimensional skin imaging to document change in atopic dermatitis severity following treatment with dupilumab in adult patients
Dr Rodney Sinclair Pty Ltd0 个研究点目标入组 15 人开始时间: 2024年8月6日最近更新:
适应症
相关药物
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Participants eligible for inclusion in the study must fulfil all the following criteria:
- •1.Male or female at least 18 years of age at time of screening.
- •2.Diagnosis of chronic atopic dermatitis for at least 6 months at Baseline.
- •3.Active atopic dermatitis present for at least 6 months from initial diagnosis
- •4.Ability to comprehend and willing to sign and date an informed consent form (ICF).
- •5.Adults who are eligible for systemic therapy or phototherapy.
- •6.Qualify for PBS-reimbursed Dupilumab. Moderate to severe atopic dermatitis as defined at study enrolment by:
- •i.PGA is equal to 4
- •ii.EASI score is greater than or equal to 20
- •iii.Documented inadequate response to topical corticosteroids or systemic immunosuppressants
- •7.The most recent documented EASI assessment must be no more than one month old at the time of starting the first dose of dupilumab
- •8.Naïve to biologics therapy for the treatment of chronic atopic dermatitis
排除标准
- •Participants fulfilling any of these criteria are not eligible for inclusion in this study:
- •1.Current treatment with systemic JAK inhibitor
- •2.Use of investigational treatments within 4 weeks before study assignment, or within a period of 5 half-lives of the investigational treatment, whichever is longer.
- •3.Previous exposure to other biologics agents such as but not limited to secukinumab, ustekinumab, brodalumab, ixikizumab, adalimumab, infliximab, briakinumab, efalizumab, golimumab, etanercept, tildrakizumab, apremilast, guselkumab and tofacitinib.
- •4.Diagnosis of other forms of inflammatory skin conditions eg psoriasis, lymphatic disease (EBV Virus), HIV, Hepatitis, Hep C, Shingles (disseminated), immunodeficiency disorders, malignancies, Tuberculosis, Thrombocytopenia, coagulopathy or platelet dysfunction.
- •5.Underlying health conditions (including but not limited to metabolic, cardiac, endocrine, neurologic, infectious and hepatic) which in the opinion of the investigator significantly immunocompromises the subject and/or places the subject at unacceptable risk for receiving an immunomodulatory therapy.
- •6.History of infections within the last 6 months requiring hospitalization.
- •7. Pregnant or lactating women; Lactating (nursing) women will need to cease prior to commencing dupilumab. This will need to be discussed with the treating physician and/or the appropriate healthcare professional.
- •8.Receiving anti-coagulants.
- •9.Received a live or attenuated vaccine within 6 weeks of day 1 visit.
- •10.Recently undergone surgery or significant trauma.
研究者
相似试验
招募中
不适用
Australian Centre of Excellence in Melanoma Imaging & Diagnosis Cohort StudyKeratinocyte skin cancerNaeviCancer - Malignant melanomaCancer - Non melanoma skin cancerSkin - Dermatological conditionsMelanomaACTRN12619001706167The University of Queensland15,000
招募中
不适用
Aquiring anatomical whole-body data by MRI meausurements for the generation of realistic computational body modelsWhole-body organ-/tissue structure, body physiqueDRKS00022423Deutsches Krebsforschungszentrum4
招募中
不适用
Diffusion-weighted whole-body imaging with background body signal suppression (DWIBS) for colorectal cancer screening.Colorectal cancerNL-OMON20182niversity medical center, Utrecht, The NetherlandsProf. dr. Siersema, MD, PhDDepartment of Gastroenterology and HepatologyUniversity Medical Center UtrechtP.O. Box 85500, 3508 GA UtrechtHeidelberglaan 100, 3584 CX UtrechtTel.nr.: +31 88 7555555Fax.nr.: +31 88 755 5533E-mail: p.d.siersema@umcutrecht.nl390
已完成
不适用
Diffusion-weighted whole-body imaging with background body signal suppression (DWIBS) at different magnetic field strengths in healthy volunteersHet betreft onderzoek naar beeldkwaliteit en normale lymfeklieren bij gezonde vrijwilligerslymph node cancerMalignant lymphomas10025323NL-OMON31117niversitair Medisch Centrum Utrecht15
已完成
不适用
Diffusion-weighted whole-body imaging with background body signal suppression (DWIBS) for colorectal cancer screeningcolon cancer1001799010017991Colorectal cancerNL-OMON33589niversitair Medisch Centrum Utrecht390